Recalls & Safety Records

Warning letterFDA · Aug 31, 2016

Bio-Stasis International, Inc 8/31/16

Named company: Bio-Stasis International, Inc.

Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded…

Warning letterFDA · Aug 26, 2016

Healing Noni Co., LLC 8/26/16

Named company: Healing Noni Co., LLC

Based on our investigation and our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs Based on FDA’s review of your…

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